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NCT Number: NCT03712774

Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant or Definitive Chemoradiation in Patients With Esophageal Cancer

Prospective observational study to evaluate the Quality of life based on standardized EORTC questionaires as well as toxicities, functional and oncological outcomes in patients treated with neoadjuvant or definitive chemoradiation for esophageal Cancer.

Recruiting

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Key information

Conditions

Quality of Life Chemoradiation Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Prospective observational study to evaluate the Quality of life based in patients treated with neoadjuvant or definitive chemoradiation for esophageal Cancer. QoL will be evaluated by standardized EORTC questionaires. Acute and late toxicity will be assessed according to CTCAE 4.03. Outcome measures will include local Control, distant Control, freedom from Treatment failure and overall survival. Correlations are planned between Patient- and physician-assessed functional Outcome.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • histologically proven esophageal Cancer (SCC or adenocarcinoma) without distant metastases (except supraclavicular nodes)
  • indication for neoadjuvant or definitive chemoradiation using either cisplatin/5-FU or carboplatin/paclitaxel with curative intent
  • age >= 18 years
  • written informed consent
  • ability to answer the standardized questionaires according to the treating physician

Exclusion criteria

  • age < 18 years
  • Treatment with palliative intent
  • distant metastases (except supraclavicular nodes)
  • second malignancy
  • Prior systemic treatment for esophageal Cancer
  • Treatment in an interventional study

Treatment and study plan

EORTC QLQ C30

Other

standardized questionaire

EORTC QLQ OES-18

Other

standardized questionaire

EORTC OG-25

Other

standardized questionaire

Primary outcomes

  1. Quality of life

    Time frame: planning CT (day 0), week 4 of RT, 6 weeks after end of RT, 3 months after end of RT, 6 months after end of RT, 12 months after end of RT, 24, 36, 48, and 60 months after end of RT

    Quality of life measured by standardized EORTC questionaires

Secondary outcomes

  1. Local control

    Time frame: 3 months after end of RT, 6 months after end of RT, 9 months after end of RT, 12 months after end of RT, 24,36,48,60 months after end of RT

    Absence of local progression

  2. Distant Control

    Time frame: 3 months after end of RT, 6 months after end of RT, 9 months after end of RT, 12 months after end of RT, 24,36,48,60 months after end of RT

    Absence of distant metastases

  3. freedom from treatment failure

    Time frame: 3 months after end of RT, 6 months after end of RT, 9 months after end of RT, 12 months after end of RT, 24,36,48,60 months after end of RT

    Absence of local and distant failure

  4. Overall survival

    Time frame: 3 months after end of RT, 6 months after end of RT, 9 months after end of RT, 12 months after end of RT, 24,36,48,60 months after end of RT

    Absence of death by any cause

  5. acute toxicity

    Time frame: end of RT, 6 weeks after end of RT, 3 months after end of RT

    acute toxicity scored according to CTCAE 4.03

  6. late toxicity

    Time frame: 6 months after end of RT, 9 months after end of RT, 12, 24, 36, 48, 60 months after end of RT

    late toxicity scored according to CTCAE 4.03

Study contacts

Contact information is provided by the study sponsor or research team.

Falk Roeder, MD

CONTACT

[email protected]

+49 89 4400 ext. 73729

Franziska Walter, MD

CONTACT

[email protected]

+49 89 4400 ext. 73770

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Acronym: ESOCARE

Important dates

Study start
2018
Primary completion
2021
Study completion
2026
First posted
Oct 19, 2018
Registry last updated
Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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